T/CNPHARS 0001-2025 Active Group standards

T/CNPHARS 0001-2025 Standard operation procedure for population pharmacokinetic-pharmacodynamic analysis

Publish Date: 2025-08-14 Implement Date: 2025-08-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CNPHARS 0001-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Biological products and blood products

ICS Name: Drugs

Publish Date: 2025-08-14

Implement Date: 2025-08-15

Scope

It is applicable to the pharmacokinetic-pharmacodynamic analysis in the process of new drug R&D and clinical drug decision-making. This group standard provides guidance and specifications for the main procedures of pharmacokinetic-pharmacodynamic analysis, including pre-analysis preparation, basic models, final models, model evaluation, model application, analysis reports, quality control, risk management, and ethics, ensuring the accuracy, reliability, and traceability of the entire analysis process, and promoting its rational development and application.